The present invention relates surgical clips for ligating or clamping vessels and ducts during surgical procedures and, in particular, a cartridge for holding and dispensing hemostat clips for surgical use.
Hemostatic clips are commonly employed in surgical procedures wherein it is desired to ligate or clamp a vessel or duct during surgery. Generally such clips are small metallic or polymeric two-legged configurations that are gripped by a custom applier and closed over the vessel. For metallic clips, the clip permanently deforms at a connecting hinge to establish a locked position. Polymeric clips, on the other hand, require latching configurations or supplemental suturing for maintaining a secure condition.
Inasmuch as the clips are extremely small and lightweight, various holders or cartridges have been proposed for holding an inventory of clips in aligned relation for ready retrieval by the surgeon at time of use. While a distinct improvement from individually selecting clips in bulk, many of the cartridges have significant drawbacks in ease of use, secure withdrawal and convenient access to the cartridge at the surgical arena. Most approaches have focused on symmetrical designs and are not well adapted for more complicated, non-symmetrical designs typical of polymeric latching clips.
For example, the clip cartridge disclosed in U.S. Pat. No. 3,326,216 to Wood provides a series of longitudinally spaced compartments having a central post adapted to compressively engage the inner surface of a two-legged V-shaped metallic clip. The width of the compartment was greater than the clip to enable a clip applier instrument, contoured to the outer periphery of the clip, to capture the clip for withdrawal therefrom. However, normal variations in manufacture of the clips, cartridges, and appliers resulted in conditions wherein the clips were not securely retained and dislodged from the cartridge, shifted in the compartment preventing removal by the applier, or interfered with insertion of the applier for removal. Moreover, the direct abrasive engagement between the applier and the cartridge resulted in abraded particulate material being carried to and deposited at the surgical site, with a consequent possibility of contamination and infection.
To overcome some the above limitations, hemostat clip cartridges have been proposed wherein the clip compartment walls are configured to compressively grip the sides of the clip for the purposes of centering the clip with respect to the applier and preventing dislodging before use. For example, U.S. Pat. No. 4,076,120 to Carroll et al. discloses a cartridge wherein tapered side walls engage and position the clip. For withdrawal, the applier is inserted into the clip compartment to deflect the side walls and permit withdrawal of the clip. However, considerable resistance to removal of the applier is created, requiring excessive withdrawal forces and requiring secure mounting of the cartridge at the surgical arena, using a variety of mechanical clamping devices. Abrasion and contamination problems were also not eliminated. To reduce withdrawal forces, side wall contact was reduced by limiting clip engagement with thin vertical ribs as disclosed in U.S. Pat. No. 4,696,393 to Samuels. Sufficient resistance was nonetheless present to require secure mounting on the cartridge for removal. Abrasion and contamination problems were not eliminated.
In another approach as disclosed in U.S. Pat. No. 4,961,499 to Kulp, it was proposed to slidingly fit a symmetrically legged clip over a conformal center post in the compartment and prevent inadvertent clip dislodgment by disposing projections above and partially overlapping the clip. During removal, the clip directly engaged the projections to deflect the side walls sufficiently to allow clip removal. Nonetheless, considerable resistance to removal remained. Moreover, the conformal support post required that the applicator be accurately aligned with the clip for removal, increasing the dexterity and time of the procedure.
In U.S. Pat. No. 4,936,447 to Peiffer, asymmetrical clips are retained in a cartridge by means of lateral interference at the side walls and by pairs of deflectable fingers that center the clip until the applier makes contact with the clip legs. As the applier makes further contact, the legs are deflected downwardly and do not interfere with clip withdrawal. During the majority of the insertion the applier is in direct contact with the clip with the resultant possibility of abrasion at the applier clip interface. Moreover, the disposition of the fingers are such that the fingers loose contact with the clip prior to the full seating with the applier. Accordingly, the clip may not be securely retained on the applier. Further, the clip support does not accommodate pivoting of the clip for alignment with the applier and as such is not well suited for asymmetrical latching clips.
Inasmuch as the asymmetrical clips have additional criteria for withdrawal, it was proposed in U.S. Pat. No. 5,201,416 to Taylor to mount the latching clip on a saddle that allowed the clip to rotate and thereby assisting in aligning the clip removal bosses with the applier. However, engagement protuberances on the compartment walls need to be deflected to remove the clips such that secure mounting at the surgical arena was necessary. Moreover, the applier jaws were positioned and guided by vertical ledges adjacent the saddle. Normal manufacturing variances in the cartridge and the applier often interacted to create interference conditions potentially contributing to abrasions. Further, the need for accurate jaw alignment necessitated dexterity for both engagement and withdrawal.
A further approach regarding latchable clips in disclosed in U.S. Pat. No. 4,361,229 to Mericle wherein a latchable polymeric clip is pivotally supported on a center post and positioned by deflectable inwardly projecting paper fingers. For removal, the applier initially deflects the fingers and subsequently captures the engagement bosses. However, prior to engagement, the alignment fingers lost contact with the clip such that the clip could assume an unbalanced position requiring substantial force and manipulation to effect seating.
In view of the foregoing, it would be desirable to provide a cartridge for holding and dispensing surgical clips wherein the cartridge could be conveniently and securely mounted, flexibly aligned for clip engagement and withdrawn with minimal resistance.
Accordingly, it is an object of the present invention to provide a surgical clip cartridge that can be conveniently and quickly mounted at the surgical arena.
A further object of the invention is to provide a hemostat clip cartridge presenting minimal resistance to clip withdrawal.
Another object of the invention is to provide a cartridge for surgical clips requiring less exacting alignment of the clip applier for effecting withdrawal of the clip.
Yet another object of the invention is to provide a cartridge for asymmetrical latchable polymeric clips wherein the potential for abrasive contact between the clip applier and the clip is minimized.
Still another object of the invention is to provide a hemostat clip cartridge wherein the clips may be flexibly retained for reception by an applier instrument.
In accomplishing the foregoing objects, the present invention provides hemostatic clip cartridge for holding and dispensing latchable polymeric hemostatic clips characterized by a pair of legs connected at proximal ends to a hinge and latching means at distal ends of the legs. The legs include including projecting engagement bosses adapted to be slidingly received by notched jaws of an applier instrument. The clips are freely supported on vertical saddles in a plurality of clip compartments that accommodate limited sliding and pivotal movement for orientation with an applier instrument. The clips are flexibly preloaded against the saddles by a pair of notched flexible arms. The arms include a distal notch presenting a low friction base surface for engaging the clip legs to provide balanced biasing on the saddles and laterally spaced fingers maintaining transverse clip orientation. The flexible suspension of the clip provides an expanded insertion alignment zone. As the applier is inserted, the arms deflect while maintaining contact with the clip contours and preventing direct contact with the applier and the clip. Thereafter, the fingers contact the bosses and downwardly deflect allowing the clip jaws to securely seat the seat bosses having avoided significant contact with the softer clip material. Thereafter, the loaded applier may be withdrawn without encountering frictional or mechanical resistance, allowing the cartridge to be mounted without mechanical devices using double-faced adhesive tape.